Patient Information on the Toronto General Hospital clinical trial on insulin-producing and ‘protected’ human islet cell transplants

Physicians at Toronto General Hospital (TGH), part of University Health Network successfully performed North America’s first transplantation of specially coated insulin-producing islet cells into a patient with Type 1 diabetes on Tuesday Feb 22, 2005. The special coating on the i slet cells protects the transplanted cells from the body’s immune system reacting against them.

The patient was released from hospital three days after the surgery and is resting at home.

This transplant is part of a clinical trial whose purpose is to determine how safe and effective the specially coated human pancreatic islets are in improving the health and quality of life of patients with Type 1 diabetes without the need for long-term anti-rejection therapy. The study is being conducted by the Multi Organ Transplant Program at TGH.

Since this clinical trial is a Phase I/II study assessing the safety and effectiveness of the procedure, the islet transplant is currently not a treatment option for patients with diabetes. Islet transplants are still experimental and are available only to people who participate in a clinical trial and meet specific criteria in the study protocol. TGH is the only hospital involved in this study and will enter patients who have already been selected.

TGH physicians emphasize that many additional patients will have to be tested in clinical trials to determine how effective and long-term this treatment will be. This will take several more years. At this time, it is unknown if the patients in the study will be able to stop using insulin, or if there will be any long-term change in their insulin requirements.

Islets are insulin-producing cell clusters found within the pancreas. In patients with diabetes, the pancreas does not produce enough insulin to regulate the body’s blood sugar level. The goal of the study is to have the transplanted cells produce enough insulin to control blood sugar levels to allow patients to either reduce or stop taking insulin entirely.

The clinical trial represents a new generation of islet transplantation technology by Amcyte Inc. of Santa Monica, California, who are the sponsors of this study.

If you would like further information about this clinical trial and other information about the Multi Organ transplant Program at TGH, please visit: www.torontotransplant.org or the UHN Public Website at www.uhn.ca.

As the largest transplant program in Canada, the Multi Organ Transplant Program (MOT) provides a broad spectrum of services currently encompassing heart, lung, liver, kidney and pancreas transplantation as well as a highly successful living donor transplant programs. The MOT program performs approximately 300 transplants annually, provides follow-up care to over 2,500 transplant recipients, and serves as a model for many other transplant centres around the world.

 02/09/2005